Zimmer Holdings, Inc. manufactures a number of products for knee replacement procedures. As part of its NexGen knee replacement line, the company made the Zimmer NexGen MIS Tibial Component. This component was created for use in minimally-invasive surgery (MIS). The Zimmer NexGen MIS Tibial Component is used to replace the patient’s tibia, or shinbone. There are two bones that extend from the knee to the ankle: the tibia and fibula. The tibia is the larger of these.
The Zimmer NexGen MIS Tibial Component is used during knee replacement procedures that involve a smaller incision in order to insert the knee replacement device. As a result, less of the patient’s tendon and muscle are cut during the knee replacement procedure. The Zimmer NexGen MIS Tibial Component was recalled in 2010 due to increased incidences of device loosening when the component was used. A number of patients who received the Zimmer NexGen MIS Tibial Component have experienced complications as a result.
NexGen MIS Tibial Component Design
The Zimmer NexGen MIS Tibial Component features two main design features that were made to benefit both surgeons and patients. The first is a drop down stem extension that measured 45 millimeters or 75 millimeters. This stem extension allowed the surgeon to elongate the component after it was already placed inside the bone marrow canal in the patient’s tibia. As a result, a better fit could be accomplished in the event that the bone marrow canal was misshapen due to injury or disease.
The other main feature of the Zimmer NexGen MIS Tibial Component was a broader, shorter keel which locked into the densest part of the patient’s bone. The keel helps the implant to stay fixed and inside the patient’s bone. It is made of fins on the sides of the implant. The ability of the implant to lock into the patient’s bone eliminated the need for cement to fix the implant in place. As a result, cement-related complications could be avoided.
NexGen MIS Tibial Component Letter
In April 2010, Zimmer responded with an “Urgent Device Correction” letter that was sent to surgeons.
The letter urged surgeons to ensure that they achieve adequate access and visualization during an MIS procedure. Due to the nature of an MIS knee replacement, the surgeon’s view is often restricted during the insertion process. This can cause less optimal placement, which may in turn lead to device failure. The letter also advised surgeons to use a drop-down stem extension when the Zimmer NexGen MIS Tibial Component was used.
Other instructions for surgeons included the need for full cementing during the implantation process. Additionally, the posterior and anterior surfaces of the tibial component were to be pressurized. The bone cement application was to be used according to the manufacturer’s instructions. To accomplish this, Zimmer instructed that previous surgical technique versions were destroyed or disregarded.
NexGen MIS Tibial Component Recall
In September 2010, the FDA issued a Class II recall for the Zimmer NexGen MIS Tibial Component. The recall was in response to 114 medical device reportings (MDRs). In these MDRs, patients reported that they experienced device loosening and the need for revision surgery to remove and replace the failed device.
The recall affected worldwide distribution of the device. It was recalled from more than ten of the United States. Additionally, the Zimmer NexGen MIS Tibial Component was recalled from more than 21 countries, including France, Germany, India, Korea, and Thailand.
Filing a Lawsuit
As of early 2013, there were nearly 30 lawsuits filed against Zimmer for different products in the NexGen Complete Knee Solution product line. These cases included cases for the Zimmer NexGen MIS Tibial Component. These federal cases have been consolidated into a multidistrict litigation (MDL) in the U.S. District Court’s Northern District of Illinois.